510(k) · Cleared
Recalled · Class II · 2023LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waldemar Link GmbH & Co. KG · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on May 28, 2021 as substantially equivalent to K103233 (Howmedica Osteonics Corp., 2011) and 3 other predicates after a 445-day review. Its family tree reaches back 15 generations to 1981. 1 later device descends from it. It has been recalled once.
- Decided
- May 28, 2021
- Review
- 445 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 15 generations to K810258 (1981). 216 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations between
- 3 generations backK131647 Trinity Acetabular SystemCorin USA · 2013
- 2 generations backK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · Recalled
- 1 generation backK190535 BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · Recalled
- This deviceK200607 LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and…Waldemar Link GmbH & Co. KG · 2021
- Descendant · cites it directly · 0 of its ownK222066 LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2023
Show all 15 generations
- Root · 15 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 14 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 13 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 12 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 11 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 10 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 9 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 8 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 7 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 6 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 5 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 4 generations backK130343 Corin Trinity Acetabular System with Extra-Long HeadsCorin USA · 2013 · Recalled
- 3 generations backK131647 Trinity Acetabular SystemCorin USA · 2013
- 2 generations backK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · Recalled
- 1 generation backK190535 BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · Recalled
- This deviceK200607 LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and…Waldemar Link GmbH & Co. KG · 2021
Most influential descendants
Showing 1 of 1 · See all- K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −14 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −13 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −12 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −11 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −10 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −9 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −8 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −7 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −6 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −5 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −4 | K130343 | Corin Trinity Acetabular System with Extra-Long Heads | Corin USA | 2013 | 2 |
| −3 | K131647 | Trinity Acetabular System | Corin USA | 2013 | — |
| −2 | K170359 | Trinity™ Dual Mobility System | Corin U.S.A. Limited | 2017 | 1 |
| −1 | K190535 | BiMobile Dual Mobility System - E-Dur Inserts | Waldemar Link GmbH & Co. KG | 2019 | 1 |
| 0 (this device) | K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and… | Waldemar Link GmbH & Co. KG | 2021 | — |
| +1 | K222066 | LINK MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 20 | 0 |
| 1995 | 11 | 0 |
| 1996 | 13 | 0 |
| 1997 | 10 | 0 |
| 1998 | 5 | 0 |
| 1999 | 12 | 0 |
| 2000 | 20 | 0 |
| 2001 | 11 | 0 |
| 2002 | 10 | 0 |
| 2003 | 9 | 0 |
| 2004 | 10 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
| 2007 | 7 | 0 |
| 2008 | 1 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103233 | Modular Dual Mobility Liner, X3 Acetabular InsertSummary page 4…Number Dual Mobility 1. Modular Dual Mobility (MDM) Liner K103233 Inserts Pro Codes: LZO, MEH Stryker Orthopaedics (How… | 2011 |
| * | K150522 | G7 Dual Mobility SystemSummary page 4…Osteonics) [Primary Predicate] 2. G7 Dual Mobility System K150522 Pro Codes: LPH, KWY, LZO, OQG Biomet Inc. (Zi… | 2015 |
| * | K190535 | BiMobile Dual Mobility System - E-Dur InsertsSummary page 4…) 3. BiMobile Dual Mobility System K190535 Pro Codes: MEH, LZO Waldemar Link GmbH & Co K… | 2019 |
| * | K182321 | MobileLink Acetabular Cup SystemSummary page 4…LZO Waldemar Link GmbH & Co KG Shell/Insert 1. MobileLink®Acetabular Cup System, Polyethylene K182321 Adapters liners in neutral, offset, 10° and 20° inclinations… | 2019 |
| † | K171273 | LINK® BiMobile (TM) Dual Mobility System | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222066 | LINK MobileLink Acetabular Cup System | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2023 | Class II | Z-2641-2023 | Under Investigation by firm | Product is labeled with incorrect offset. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 40 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 59 of the 215 ancestors have a recall of any class.
- Of its descendants, K222066 (Waldemar Link GmbH & Co. KG, 2023) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K103233.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
General indications:
The MobileLink(R) Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
Indications:
1) Primary and secondary osteoarthritis
2) Rheumatoid arthritis
3) Correction of functional deformities
4) Avascular necrosis
5) Femoral neck fractures
6) Revision after implant loosening dependent on bone mass and quality
The MobileLink(R) Dual Mobility Insert is additionally indicated for:
7) Dislocation risks
The MobileLink(R) Acetabular Shells are intended for cementless fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200607: LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200607
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026